Myofunctional Therapy for Obstructive Sleep Apnea

Overseen By Marissa Anderson, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Renal disease, Liver disease, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to explore a new way to examine the function of the muscles using a technique called high-resolution manometry. The study will enroll 30 adults with OSA, all of whom will use the myofunctional therapy (MFT) devices for 3 months. High-resolution manometry will be used to measure the amount of pressure generated by the muscles of the throat when drinking water or breathing air, both with and without the MFT devices, and before and after the MFT intervention. If successful, this method can help us understand why sleep improves after MFT.

Who Is on the Research Team?

Jesse Hoffmeister, PhD, CCC-SLP

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adults with Obstructive Sleep Apnea (OSA) are eligible for this trial. Participants will use myofunctional therapy devices and undergo high-resolution manometry to measure throat muscle function during the study.

Inclusion Criteria

I am between 18 and 65 years old.

I have been newly diagnosed with sleep apnea or my first treatment didn't work.

I am willing to stop or not start standard OSA treatment for 3 months.

Exclusion Criteria

I have severe difficulty breathing through my nose.

Severe post-traumatic stress disorder (PCL-5 > 33)

Severe ankyloglossia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use myofunctional therapy (MFT) devices for 3 months, including high-intensity swallowing exercises and respiratory muscle strength training

12 weeks

2 visits (in-person) before and after the intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Myofunctional Therapy

Trial Overview

The trial is testing myofunctional therapy (MFT), a technique that may improve sleep by strengthening throat muscles in OSA patients. The effectiveness of MFT is measured using high-resolution manometry before and after the intervention.

How Is the Trial Designed?

Group I: Myofunctional Therapy Experimental Treatment 1 Intervention

The intervention consists of 90 days of MFT (5-6 days/week) along with completing daily logs. MFT will include high-intensity swallowing exercises and respiratory muscle strength training. Before and after the MFT intervention period, there will be a research visit that includes answering questionnaires about symptoms and health, performing throat HRM, and assessing oral and facial muscles involved in swallowing.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+